A Phase II Clinical Study of LCB01-0371 to Evaluate the EBA, Safety and PK

LigaChem Biosciences, Inc.79 enrolled

Overview

A Prospective, Randomized, Open, Active-controlled, Interventional, Exploratory, Phase II Trial of LCB01-0371.

This study is designed to explore antituberculosis of LCB01-0371 through the assess of the early bactericidal activity, safety of administration.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulmonary Tuberculosis

Interventions

LCB01-0371 800mg, QDDRUG

Oral administration

LCB01-0371 400mg, BIDDRUG

Oral administration

LCB01-0371 800mg, BIDDRUG

Oral administration

Tubes 3~5Tablet, QD

Eligibility

Sex: ALLMin age: 19 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Korean who After listening to understand the details about the clinical trial, decided to join in the clinical study, and written consent 2. The age of consent at the time of writing, only men and women under 75 years old over 19 years old 3. The First diagnosis of tuberculosis and have not received tuberculosis treatment for TB patients Exclusion Criteria: 1. Known history of Rifampicin or Isoniazid resistance 2. Serious TB for example tuberculous encephalomeningitis, It is impossible to participate in clinical trials 3. Known History of nontuberculous mycobacteria positive 4. Other pulmonary disease which is impossible to participate in clinical trial except TB

Locations (1)

Asan Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

EBA0-14

The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from baseline at Day 15

Time frame: V2(Baseline, Day 1), V9(Day 15)

Secondary Outcomes

EBA0-2

The standard early bactericidal activity (standard EBA) expressed as the change of log colony forming units of sputum from baseline at Day 3

Time frame: V2(Baseline, Day 1), V4(Day 3)

EBA2-14

The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from Day 3 at Day 15

Time frame: V4(Day 3), V9(Day 15)

EBA2-7

The extended early bactericidal activity (extended EBA) expressed as the change of log colony forming units of sputum from Day 2 at Day 8

Time frame: V4(Day 3), V6(Day 8)

Data from ClinicalTrials.gov

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